510(k) K912255— HYCOR PYLORAGEN HELICOBACTER PYLORI TEST

Substantially Equivalent

Hycor Biomedical, Inc.

Clearance details

Applicant: Hycor Biomedical, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1991-05-22
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.